Oral Appliances for Obstructive Sleep Apnea

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ORAL APPLIANCES FOR OBSTRUCTIVE SLEEP APNEA HS-057

Clinical Coverage Guideline page 1 Original Effective Date: 11/6/2008 - Revised: 11/11/2009, 11/12/2010, 10/6/2011, 11/1/2012, 11/7/2013, 11/6/2014, 11/5/2015

Easy Choice Health Plan, Inc.

Exactus Pharmacy Solutions, Inc.

Harmony Health Plan of Illinois, Inc.

Missouri Care, Incorporated

WellCare Health Insurance of Arizona, Inc., operating in Hawai‘i as ‘Ohana Health Plan, Inc.

WellCare of Kentucky, Inc.

WellCare Health Plans of Kentucky, Inc.

WellCare Health Plans of New Jersey, Inc.

WellCare of Connecticut, Inc.

WellCare of Florida, Inc., operating in Florida as Staywell

WellCare of Georgia, Inc.

WellCare of Louisiana, Inc.

WellCare of New York, Inc.

WellCare of South Carolina, Inc.

WellCare of Texas, Inc.

WellCare Prescription Insurance, Inc.

Windsor Health Plan, Inc.

Oral Appliances for Obstructive Sleep Apnea

Policy Number: HS-057 Original Effective Date: 11/6/2008

Revised Date(s): 11/11/2009;

11/12/2010; 10/6/2011; 11/1/2012;

11/7/2013; 11/6/2014; 11/5/2015

APPLICATION STATEMENT

The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any.

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ORAL APPLIANCES FOR OBSTRUCTIVE SLEEP APNEA HS-057

DISCLAIMER

The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member’s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member’s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Note: Lines of business (LOB) are subject to change without notice; current LOBs can be found at www.wellcare.com – select the Provider tab, then

“Tools” and “Clinical Guidelines”.

BACKGROUND

Sleep apnea syndrome (SAS) is a sleep-related breathing disorder defined as the cessation of breathing for an interval of > 10 seconds recurring repetitively (> 10 times per hour) throughout sleep. During sleep, upper airway muscle tone and resistance decrease and increase, respectively, causing collapse of the upper airway. This collapse leads to total obstruction (apnea) or partial obstruction (hypopnea) of the upper airway, resulting in decreased arterial oxygen saturation (SaO2) and disruption in normal sleep architecture. While anyone may experience apneic episodes, the frequency and duration of these episodes increase in the presence of a variety of anatomic and functional abnormalities that result in decreased upper airway space, respiratory strength, or ventilatory drive. In general, SAS is categorized according to its cause. Obstructive sleep apnea (OSA) is caused by reduced upper airway space due to the normal sleep-related collapse of the upper airway, as well as abnormalities that further reduce upper airway space.^1,2

Nasal continuous positive airway pressure (CPAP or nCPAP), is considered the standard of care for treatment of SAS. However, a sizable number of apnea patients cannot tolerate the device, and compliance rates are

correspondingly low. Several modifications to traditional CPAP, as well as a number of other alternative nonsurgical devices have been proposed.Devices have been created to be used either in patients with mild disease who cannot tolerate CPAP or who have not responded to or are not suitable candidates for surgery. The literature indicates that most of these devices are relatively free of serious side effects in most patient populations and produce acceptable reductions among outcome parameters, such as the apnea/hypopnea index (AHI). Dental prosthetic devices have recently gained popularity as a treatment for OSA. This popularity is partially due to the ease of using the dental device and to poor tolerance and compliance often associated with CPAP use. Several different intraoral devices can be used to treat OSA. They can be divided into two groups: (1) those that hold the tongue forward during sleep (tongue-retaining devices); (2) and those that advance the mandible (anterior mandibular positioning or mandibular advancement devices). The other common form of OSA treatment is a mandibular repositioning appliance which is believed to act by advancing the mandible and increasing upper airway size. It has recently been shown that

prosthetic appliances used in the treatment of OSA activate masticatory and tongue muscles during sleep to prevent the upper airway from collapsing.^1,2

POSITION STATEMENT Applicable To:

Medicaid – All Markets Medicare – All Markets Exclusions

If criteria A-D below are not met, the custom fabricated oral appliance (E0486) will be denied.

Coverage

An oral appliance is considered medically necessary if ALL of the following criteria are met:

1) The member has a clinical evaluation by the treating physician (MD or DO) before the performance of a sleep test to assess the member for obstructive sleep apnea; AND,

2) The member has a sleep test (see below for criteria) that confirms that:

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ORAL APPLIANCES FOR OBSTRUCTIVE SLEEP APNEA HS-057

a. The apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) is greater than or equal 15 events per hour with a minimum of 30 events; OR;

b. The AHI or RDI is greater than or equal to 5 events and less than or equal to 14 events per hour with a minimum of 10 events total and documentation of:

 Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; OR,

 Hypertension, ischemic heart disease, or history of stroke.

c. If the AHI >30 or the RDI >30 and meets one of the following:

a. The member is not able to tolerate a positive airway pressure device; OR b. The treating physician determines that the use of said device is contraindicated.

3) The device is ordered by the treating physician following review of the report of the sleep test.

NOTE: The physician providing the order for the oral appliance can be different from than the physician performing the clinical evaluation.

4) The device is provided and billed for by a licensed dentist (DDS or DMD).

NOTE: If criteria A-D are not met, the custom fabricated oral appliance (E0486) will be denied as not reasonable and necessary.

Sleep Test Requirements

The sleep test performed must be a:

1) Polysomnogram (or a Type 1 sleep test) performed in a facility-based laboratory. A Type I sleep test is the continuous and simultaneous monitoring and recording of various physiological and pathophysiological parameters of sleep with physician review, interpretation, and report. It is facility-based and must include sleep staging, which is defined to include a 1-4 lead electroencephalogram (EEG), and electro-oculogram (EOG), submental electromyogram (EMG) and electrocardiogram (ECG). It must also include at least the following additional parameters of sleep: airflow, respiratory effort, and oxygen saturation by oximetry. It may be performed as either a whole night study for diagnosis only or as a split night study to diagnose and initially evaluate treatment.

2) A home sleep test (HST) is performed unattended in the beneficiary's home using a portable monitoring device. A portable monitoring device for conducting an HST must meet one of the following criteria:

a. Type II device – Monitors and records a minimum of seven (7) channels: EEG, EOG, EMG, ECG/heart rate, airflow, respiratory movement/effort and oxygen saturation; or,

b. Type III device – Monitors and records a minimum of four (4) channels: respiratory movement/effort, airflow, ECG/heart rate and oxygen saturation; or,

c. Type IV device - Monitors and records a minimum of three (3) channels, one of which is airflow; or, d. Other - Devices that monitor and record a minimum of three (3) channels that include actigraphy,

oximetry and peripheral arterial tone and for which there is substantive clinical evidence in the published peer-reviewed medical literature that demonstrates that the results accurately and reliably correspond to an AHI or RDI as defined above. This determination will be made on a device-by-device basis

(WatchPAT (Itamar Medical) is currently the only approved device in this category).

Members who undergo a HST must receive instruction on how to properly apply a portable sleep monitoring device prior to having the sleep test. Instruction must be provided by the entity conducting the HST and may not be performed by a DME supplier. Instruction may be accomplished by either:

 Face-to-face demonstration of the portable sleep monitoring device's application and use; or,

 Video or telephonic instruction, with 24-hour availability of qualified personnel to answer questions or troubleshoot issues with the device.

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ORAL APPLIANCES FOR OBSTRUCTIVE SLEEP APNEA HS-057

All sleep tests must be interpreted by a physician who holds either:

 Current certification in Sleep Medicine by the American Board of Sleep Medicine (ABSM); or,

 Current subspecialty certification in Sleep Medicine by a member board of the American Board of Medical Specialties (ABMS); or,

 Completed residency or fellowship training in a program approved by an ABMS member board and has completed all the requirements for subspecialty certification in sleep medicine except the examination itself and only until the time of reporting of the first examination for which the physician is eligible; or,

 Active staff membership of a sleep center or laboratory accredited by the American Academy of Sleep Medicine (AASM), Accreditation Commission for Health Care (ACHC) or The Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations – JCAHO).

NOTE: No aspect of an HST, including but not limited to delivery and/or pickup of the device, may be performed by a DME supplier. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.

Follow-Up. To ensure satisfactory therapeutic benefit for the appliance, the member should undergo

polysomnography with the oral appliance in place after final adjustments of fit have been performed. Once optimal fit is obtained and efficacy shown, dental specialist follow up every 6 months is recommended for the first year, and at least annually thereafter.

Members with obstructive sleep apnea who are treated with oral appliances should return for follow-up visits with the referring physician to assess the member for current severity of signs and symptoms of obstructive sleep apnea.

CODING

CPT®* Codes – No applicable codes.

ICD-9-CM Procedure Codes – No applicable codes.

Covered HCPCS Level II ® Codes

E0485 Oral device/appliance used to reduce upper airway collapsibility, adjustable or nonadjustable, prefabricated, includes fitting and adjustment

E0486 Oral device/appliance used to reduce upper airway collapsibility, adjustable or nonadjustable, custom fabricated, includes fitting and adjustment

Covered ICD-9-CM Diagnosis Code

327.23 Obstructive sleep apnea (adult) (pediatric)

ICD-10 Diagnosis Code

G47.33 Obstructive sleep apnea (adult) ( pediatric)

REFERENCES

1. Kushida CA, Morgenthaler TI, Littner MR, Alessi CA, Bailey D, Coleman J, et al. Practice parameters for the treatment of snoring and obstructive sleep apnea with oral appliances: an update for 2005. Sleep. 2006:29(2), 240-243.

2. Local coverage determination for oral appliances for obstructive sleep apnea (L28620). Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published June 29, 2012. Accessed October 16, 2015.

MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS

Date Action

11/5/2015, 11/6/2014, 11/7/2013  Approved by MPC. No changes.

11/1/2012  Approved by MPC. Added new CMS LCD reference, including information on Home Sleep Test criteria. No other changes.

12/1/2011  New template design approved by MPC.

10/6/2011  Approved by MPC. Reformatted references (delete one); no major changes. Reformatted references (delete one); no major changes. Added to References Final LCD # L28620 Oral Applicances for Obstructive Sleep Apnea. (DL28620 was a Draft LCD in 2010, L28620 is the Final). Delete Code S8262 for 2011 as not applicable.